0.01% and 0.025% Atropine Eye Drops Combined Auricular Acupoint Stimulation on Myopia Control and Corneal Endothelium Change

Официальное название

A Pilot Randomized, Partially Double Blind, Placebo-Controlled Trial of 0.01% and 0.025%Atropine Eye Drops Combined Auricular Acupoint Stimulation on Myopia Control and Corneal Endothelium Change

Обзор

This randomized, double-blind, placebo-controlled pilot trial evaluates the efficacy and safety of low-dose atropine (0.01%, 0.025%) combined with auricular acupoint stimulation for myopia control in children. While 0.05% atropine is effective, it may pose corneal toxicity risks, highlighting the need for safer alternatives. Auricular acupuncture has shown potential benefits in systematic reviews. A total of 420 children aged 6-12 will be randomized into six groups receiving different treatments or placebo, with a 12-week follow-up. The auricular Eye Point will be stimulated, and comprehensive visual and ocular assessments will be conducted, including corneal endothelial monitoring. This study aims to determine the synergistic effect of combined therapy and provide a safer treatment option, laying the foundation for future large-scale trials.

Подробное описание

This study is a randomized, double-blind, placebo-controlled pilot clinical trial designed to investigate the efficacy and safety of low-concentration atropine eye drops (0.01% and 0.025%) combined with auricular acupoint stimulation in controlling myopia in children.

Although 0.05% atropine has been proven effective in slowing the progression of myopia, higher concentrations may pose a risk of corneal endothelial toxicity. Therefore, alternative strategies that balance efficacy and safety are needed. Auricular acupuncture, a traditional Chinese medicine (TCM) technique, has shown potential benefits for myopia control in children in systematic reviews. This study aims to evaluate the synergistic effects of combining both interventions.

A total of 420 children aged 6 to 12 years are expected to be recruited and randomly assigned into six groups receiving different concentrations of atropine, auricular acupoint stimulation, or placebo treatment. The study will include a 12-week follow-up period. Auricular Eye Point, which is commonly used in clinical practice, will be stimulated. Each participant will undergo a comprehensive assessment of visual function, including keratometer, spherical equivalent, Amplitude of accommodation, axial length, anterior chamber depth, intraocular pressure, corneal topographic map, optical coherence tomography, central corneal thickness. Corneal endothelial cell parameters will also be monitored to evaluate safety.

This study aims to confirm the adjunctive effect of auricular acupoint stimulation combined with low-concentration atropine in controlling myopia and to provide a safer, low-side-effect treatment option for children. The findings are expected to lay the groundwork for future large-scale clinical trials.

Вмешательства

• Другое Auricular acupoint stimulation
  Auricular Eye Point
• Препарат 0.01% concentration atropine drops
  0.5 mL unit dose, preservative-free
• Препарат 0.025% atropine eye drops
  0.5 mL unit dose, preservative-free
• Другое Artificial Tears (AT)
  0.5 mL unit dose, preservative-free

Первичные конечные точки

• Change in corneal curvature (Keratometry) [Срок оценки: Baseline to 3 months once per week.]
• Change in refractive error (Spherical Equivalent) [Срок оценки: Baseline to 3 months once per week.]
• Change in amplitude of accommodation [Срок оценки: Baseline to 3 months once per week.]
• Change in axial length [Срок оценки: Baseline to 3 months once per week.]
• Change in anterior chamber depth [Срок оценки: Baseline to 3 months once per week.]
• Change in intraocular pressure [Срок оценки: Baseline to 3 months once per week.]
• Change in corneal topographic parameters [Срок оценки: Baseline to 3 months once per week.]
• Change in retinal structure assessed by optical coherence tomography [Срок оценки: Baseline to 3 months once per week.]
• Change in central corneal thickness [Срок оценки: Baseline to 3 months once per week.]

Критерии участия

Критерии включения

• Children aged 6-12 years
• Myopia after cycloplegia (spherical equivalent > -0.5 D)
• Astigmatism and anisometropia < -2.0 D
• Intraocular pressure < 21 mmHg

Критерии исключения

• Infection
• Ulceration
• Eyelid disorders
• Ear disorders
• Amblyopia or strabismus
• Use of other pharmacological or invasive treatments for myopia during the study period (spectacles allowed)
• Hematologic or other systemic diseases
• Non-compliance with study protocol for more than 7 days
• History of atropine allergy
• Previous or current use of contact lenses or orthokeratology lenses
• Previous or current use of bifocal or progressive lenses

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• China Medical University Hospital — Taichung

Идентификаторы

NCT: NCT07537166 · CMUH114-REC1-146

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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